Plasma exchange and glucocorticoids to delay death or end-stage renal disease in anti-neutrophil cytoplasm antibody-associated vasculitis: PEXIVAS non-inferiority factorial RCT
| Autor: | David Jayne, Michael Walsh, Peter A Merkel, Chen Au Peh, Wladimir Szpirt, Xavier Puéchal, Shouichi Fujimoto, Carmel Hawley, Nader Khalidi, Rachel Jones, Oliver Flossmann, Ron Wald, Louis Girard, Adeera Levin, Gina Gregorini, Lorraine Harper, William Clark, Christian Pagnoux, Ulrich Specks, Lucy Smyth, Toshiko Ito-Ihara, Janak de Zoysa, Biljana Brezina, Andrea Mazzetti, Carol A McAlear, Donna Reidlinger, Samir Mehta, Natalie Ives, Elizabeth A Brettell, Hugh Jarrett, Keith Wheatley, Elizabeth Broadhurst, Alina Casian, Charles D Pusey |
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| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: | |
| Zdroj: | Health Technology Assessment, Vol 26, Iss 38 (2022) |
| Druh dokumentu: | article |
| ISSN: | 1366-5278 2046-4924 |
| DOI: | 10.3310/PNXB5040 |
| Popis: | Background: Anti-neutrophil cytoplasm antibody-associated vasculitis is a multisystem, autoimmune disease that causes organ failure and death. Physical removal of pathogenic autoantibodies by plasma exchange is recommended for severe presentations, along with high-dose glucocorticoids, but glucocorticoid toxicity contributes to morbidity and mortality. The lack of a robust evidence base to guide the use of plasma exchange and glucocorticoid dosing contributes to variation in practice and suboptimal outcomes. Objectives: We aimed to determine the clinical efficacy of plasma exchange in addition to immunosuppressive therapy and glucocorticoids with respect to death and end-stage renal disease in patients with severe anti-neutrophil cytoplasm antibody-associated vasculitis. We also aimed to determine whether or not a reduced-dose glucocorticoid regimen was non-inferior to a standard-dose regimen with respect to death and end-stage renal disease. Design: This was an international, multicentre, open-label, randomised controlled trial. Patients were randomised in a two-by-two factorial design to receive either adjunctive plasma exchange or no plasma exchange, and either a reduced or a standard glucocorticoid dosing regimen. All patients received immunosuppressive induction therapy with cyclophosphamide or rituximab. Setting: Ninety-five hospitals in Europe, North America, Australia/New Zealand and Japan participated. Participants: Participants were aged ≥ 16 years with a diagnosis of granulomatosis with polyangiitis or microscopic polyangiitis, and either proteinase 3 anti-neutrophil cytoplasm antibody or myeloperoxidase anti-neutrophil cytoplasm antibody positivity, and a glomerular filtration rate of |
| Databáze: | Directory of Open Access Journals |
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